Esophageal Cytology With FISH in Detecting Esophageal Cancer

NCT02100189 | Completed Results DMC

• 3 other identifiers: IRB00009213NCI-2014-00384P30CA069533
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.

Conditions

Dysphagia; Dysplasia; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Esophagitis; Gastroesophageal Reflux Disease; High Grade Dysplasia in Barrett Esophagus; Weight Loss

Outcome Measures

Primary Outcomes (2)

• Sensitivity of Sponge Cytology Using FISH

  All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

  At the time of sponge cytology and EGD

• Specificity of Sponge Cytology Using FISH

  All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

  At the time of sponge cytology and EGD

Secondary Outcomes (2)

• Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  At the time of sponge cytology procedure

• Tolerability of FISH Spongy Cytology

  After completion of FISH and EGD

Study Arms (1)

Screening (esophageal cytology, FISH)

EXPERIMENTAL

Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Other: Cytology Specimen Collection Procedure; Procedure: Esophagogastroduodenoscopy; Other: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo esophageal cytology collection

Also known as: Cytologic Sampling

Screening (esophageal cytology, FISH)

Esophagogastroduodenoscopy PROCEDURE

Undergo standard EGD or endoscopy

Also known as: EGD

Screening (esophageal cytology, FISH)

Laboratory Biomarker Analysis OTHER

Correlative studies

Screening (esophageal cytology, FISH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with known esophageal cancer diagnosed by previous endoscopy
• Adenocarcinoma
• Squamous cell carcinoma
• Patients determined to be at risk for esophageal cancer:
• Subjects with a history of Barrett's esophagus
• Subjects with a history of low or high grade dysplasia
• Subjects with a history of gastroesophageal reflux disease (GERD)
• Subjects with a history of esophagitis
• Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
• Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
• Upper endoscopy
• Surgical esophagectomy
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 (Karnofsky \>= 30%) will be included
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Subjects with severe, symptomatic dysphagia (unable to pass solids)
• Subjects that are unable to swallow a tablet/pill for any reason
• Subjects with a previous esophagectomy
• Subjects with esophageal varices
• Subjects unable to provide consent
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma; Esophagitis; Gastroesophageal Reflux; Weight Loss

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Gastroenteritis; Esophageal Motility Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: John Hunter, MD
• Organization: OHSU

hunterj@ohsu.edu

503-494-4937

Study Officials

• John Hunter

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Dean

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 31, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-05

Locations

US (1)